Will the Final Guidance on Biosimilar Naming Be Reversed?

Judging from the comments at the Academy of Managed Care Pharmacy’s (AMCP’s) annual meeting March 27–30 in Denver, there is some hope and expectation that the Trump Administration will review and possibly revoke the naming convention for biologics and biosimilars that was finalized just recently.

The Academy’s position on the naming convention has not changed, according to Mary Jo Carden, VP of Government and Pharmacy Affairs. She characterized the naming convention chosen by the Food and Drug Administration (FDA) as unnecessary and confusing. Therefore, AMCP is still in favor of using the government-approved name and international nonproprietary name to biosimilars (and no new suffixes to existing originator products). In previous comments to the FDA, the Academy wrote, “AMCP supports a biosimilar naming convention using the same INN that has proven safe and effective globally for small molecule drugs and for biological products in Europe, and therefore it should be the standard in the United States. Using the same INN for biosimilars would also alleviate the need for multiple product identifiers in biosimilar labeling and therefore eliminate the potential for confusion by health care providers and patients.”

Doug Long, MBA, VP of Industry Relations at QuintilesIMS, in answer to a question from the audience, said he “might mention it to Scott Gottlieb,” newly nominated FDA Commissioner, to revisit it after his confirmation. Especially in light of the present administration’s statements to streamline the drug approval process and improve public access to less-expensive medications, this would seem to make sense. Mr. Long also said that he had difficulty fathoming the reasons behind the decision making on biosimilar naming.

Drug consultant C. Douglas Monroe, RPh, MS, pointed out that there is hope. The Office of Management and Budget has asked the FDA to postpone implementation, and public comments from numerous organizations railed against the policy. Mr. Monroe cited publisher Wolters Kluwer as saying that the “…FDA’s proposed naming approach is a solution in search of a problem.” And several organizations, such as NCPDP and drug manufacturers, complained of the time and billions in cost of applying suffixes to all existing biologics.

Although it may be appealing for the Trump Administration to simply scrap the existing final guidance on naming. If they do not simply revert to the basic INN nomenclature for biologics, do we really want to start the entire process of considering a new system from scratch again?